Pharmaceutical and medtech companies can face serious challenges when GMP issues begin to affect product quality, operational performance or regulatory confidence. Many facilities struggle with recurring deviations, contamination events, incomplete documentation or gaps raised during inspections. Our GMP Remediation and Quality Systems service provides the structured support needed to identify risks, respond quickly and restore full and sustainable GMP compliance.

This is where our cGMP compliance and contamination control expertise delivers maximum value. We help you regain control, reduce regulatory pressure and build a stronger, more resilient operation.

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Rapid Risk Identification and Targeted Remediation

When GMP issues appear, speed and accuracy matter.
We work with clients to identify root causes and define a remediation plan that is clear, achievable and aligned with regulatory expectations.

Support includes:
• Early identification of GMP and contamination control risks
• Assessment of deviations, CAPA effectiveness and quality gaps
• Review of environmental, cleaning and utility performance
• Verification of documentation, traceability and decision records
• Prioritised action plans to protect product, patient and company

Our approach gives you clarity during difficult periods and helps you act with confidence.

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Expert Onsite Teams to Support Recovery

Many remediation efforts fail because internal teams do not have enough time or specialist expertise.
We provide experienced onsite support that integrates directly with QA, QC, Manufacturing, Engineering and Validation.

Our teams help you:
• Strengthen day-to-day GMP oversight
• Improve deviation management and root cause analysis
• Execute remediation actions and verify effectiveness
• Support shutdowns, cleaning programmes and contamination investigations
• Restore routine control across critical operations

This provides the capacity and expertise needed to recover quickly.

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Audit-Ready Tools, Templates and Documentation

Regulators expect clear, consistent and defensible documentation.
We provide all the tools needed to demonstrate strong remediation progress.

Support includes:
• Updated SOPs, forms and controlled templates
• Revised risk assessments and contamination controls
• CAPA documentation aligned with EU GMP and FDA expectations
• Validation updates for equipment, utilities and processes
• Supporting documents for inspection responses and follow-up actions

This helps you respond with confidence during audits and regulatory interactions.

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Strengthening the Quality Management System

Sustainable compliance depends on a strong QMS.
We support improvements across all major elements of the quality system.

Support includes:
• QMS redesign and governance improvements
• Operational oversight of QA, QC, Manufacturing and Engineering
• CMMS and maintenance programme improvements
• Cleaning and sanitisation upgrades
• Review of training, competencies and documentation discipline
• Integration of contamination control principles into core procedures

This reduces the chance of repeat findings and stabilises your operation.

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Support for Facility Upgrades and Capital Projects

Some remediation needs require new equipment or facility upgrades.
We help you plan and justify CapEx decisions and support execution activities.

Support includes:
• Clean utility replacements and system upgrades
• Equipment selection, URS development and qualification planning
• Facility modifications to correct workflow or segregation issues
• Coordination with CQV and engineering teams

This ensures capital investments directly improve compliance and long-term performance.

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Value for Your Organisation

• Faster recovery from GMP or contamination issues
• Clear and defensible remediation actions for regulators
• Stronger QMS and improved operational control
• More effective oversight across QA, QC, Manufacturing and Engineering
• Reduced downtime and fewer recurring deviations
• A sustainable return to full compliance and operational stability

Clients gain a structured, reliable remediation partner who provides both strategy and execution, supported by deep cGMP and contamination control expertise.